A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

Summary

The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).

Timeline

Start

2011-12-15

Primary completion

2020-02-24

Completion

2020-02-24

Publications

• Konecny GE, Davidson TM, Lebreton CL, Marsh LA, Chetram DK, Atkinson HJ, Larson MC, Oberg AL, Abdelaal N, Silverstein J, Jatoi A, Washburn A, Burton J, Dowdy S, Zhang L, Hallberg D, Velculescu VE, Slamon DJ, Wahner-Hendrickson AE. Phase II study of the efficacy and safety of palbociclib in patients with recurrent ovarian cancer. Int J Gynecol Cancer. 2025 Oct;35(10):102028. doi: 10.1016/j.ijgc.2025.102028. Epub 2025 Jul 28.

Drugs

Indications